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Doctors in Germany protest at a new restrictive law on tissue banks

BMJ 2006; 333 doi: (Published 12 October 2006) Cite this as: BMJ 2006;333:774
  1. Annette Tuffs
  1. Heidelberg

    Doctors in Germany say that patients will suffer if a proposed new law regulating use of human tissue is passed. The law will state that donated tissue must be subject to the same strict regulation as pharmaceutical products.

    The German Medical Association and the Association of Surgeons are demanding that the law be amended so that tissues are regulated under Germany's Transplant Act rather than the Pharmaceuticals Act. This would ensure that the tissues are safe and would prevent the commercialisation of tissue donation, proponents of the law say. The law does not change the rules for tissue donation—like organs, tissues can be removed if the dead person has a donor card or if relatives agree—but it does change the rules for storing tissues.

    Doctors say that special rules should apply only to tissues that have to be prepared for further use in medical devices or as implants or to egg or sperm cells and not to all human tissue.

    In August 2006 the German government decided that, to fulfil European Union regulations, tissues such as corneas, heart valves, bone cartilage, stem cells, and egg and sperm cells should come under the amended Pharmaceuticals Act. Hospitals and tissue banks must fulfil the same high criteria as drug manufacturers, even if the tissues are only conserved and not processed for further use.

    “To run a tissue bank will become very expensive. Tissue banks will have to close, and the beneficial exchange of tissues with other European countries will be virtually impossible,” said Roland Hetzer, director of the German Heart Institute in Berlin, at a press conference.

    Klaus Theo Schröder, secretary of state in the German health ministry, said in an official statement that the new law was needed to protect the safety of patients. He also said that it would not raise costs. This is disputed by health insurance companies, who say it will add hundreds of thousands of euros to the cost of keeping human tissue, because of the safety measures, licences, and insurance that are obligatory under the Pharmaceuticals Act.

    The law will open the door to a trade in human tissue, the critics say. Organ and tissue transplantation should remain in the hands of non-profit organisations, with a priority given to removing and transplanting whole organs, such as hearts (rather than heart valves).

    Furthermore, the critics request that different tissues should be dealt with in different ways. Human tissue that is conserved and frozen, like bone marrow, blood vessels, and heart valves, should come under the Transplant Act. Only tissue that has to be processed for further medical use or as a drug justifies their coming under drug manufacturing regulations. A special solution should be found for sperm and egg cells, because the term “drug” can not apply to them, the critics say.

    In October 2006 the new law will be discussed in the Bundesrat, the Council of all 16 German states, before parliament will have to decide.

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